EULAR recommendations for the health professional's approach to pain management in inflammatory arthritis and osteoarthritis.

Pain is the predominant symptom for people with inflammatory arthritis (IA) and osteoarthritis (OA) mandating the development of evidence-based recommendations for the health professional's approach to pain management. A multidisciplinary task force including professionals and patient representatives conducted a systematic literature review of systematic reviews to evaluate evidence regarding effects on pain of multiple treatment modalities. Overarching principles and recommendations regarding assessment and pain treatment were specified on the basis of reviewed evidence and expert opinion. From 2914 review studies initially identified, 186 met inclusion criteria. The task force emphasised the importance for the health professional to adopt a patient-centred framework within a biopsychosocial perspective, to have sufficient knowledge of IA and OA pathogenesis, and to be able to differentiate localised and generalised pain. Treatment is guided by scientific evidence and the assessment of patient needs, preferences and priorities; pain characteristics; previous and ongoing pain treatments; inflammation and joint damage; and psychological and other pain-related factors. Pain treatment options typically include education complemented by physical activity and exercise, orthotics, psychological and social interventions, sleep hygiene education, weight management, pharmacological and joint-specific treatment options, or interdisciplinary pain management. Effects on pain were most uniformly positive for physical activity and exercise interventions, and for psychological interventions. Effects on pain for educational interventions, orthotics, weight management and multidisciplinary treatment were shown for particular disease groups. Underpinned by available systematic reviews and meta-analyses, these recommendations enable health professionals to provide knowledgeable pain-management support for people with IA and OA.

Comparing physical therapy students' attitudes and beliefs regarding chronic low back pain and knee osteoarthritis: an international multi-institutional comparison between 2013 and 2020 academic years.

BACKGROUND: In 2013, physical therapy students demonstrated low guideline-adherent recommendations regarding chronic low back pain (CLBP) for spinal pathology, activity, and work. OBJECTIVES: To assess the differences in physical therapy students' attitudes, beliefs, and adherence to guideline recommendations regarding CLBP and knee osteoarthritis between 2013 and 2020. METHODS: In 2013 and 2020, second and fourth-year physical therapy students were recruited from 6 Belgian and 2 Dutch institutions. Attitudes and beliefs regarding CLBP and knee OA were evaluated using the Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT), the Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS), and a questionnaire regarding therapeutic exercise and knee osteoarthritis. A clinical vignette was used to measure guideline-adherent recommendations regarding spinal pathology, activity, and work. RESULTS: In 2013, 927 second-year and 695 fourth-year students; in 2020, 695 second-year and 489 fourth-year students; were recruited to participate in the study. Compared to 2013, students had less biomedical and stronger biopsychosocial attitudes and beliefs regarding CLBP, more guideline-adherent recommendations for activity, and more biopsychosocial beliefs regarding the benefits of exercise for patients with knee osteoarthritis in both the second and fourth year. Only fourth-year students in 2020 scored significantly better on HC-PAIRS and guideline-adherent recommendation relating to spinal pathology. No differences were found regarding work recommendations. CONCLUSIONS: Between 2013 and 2020, physical therapy students made a positive shift towards a more biopsychosocial approach to CLBP and knee osteoarthritis management. Guideline-adherent recommendations for CLBP concerning activity improved, however, concerning work and spinal pathology, it remained low.

Physiotherapists Using the Biopsychosocial Model for Chronic Pain: Barriers and Facilitators-A Scoping Review.

The use of the biopsychosocial model in primary care physiotherapy for chronic pain is far from the recommendations given in research and current guidelines. To understand why physiotherapists have difficulty implementing a biopsychosocial approach, more insight is needed on the barriers and facilitators. This scoping review aimed to investigate and map these barriers and facilitators that physiotherapists working in primary care reportedly face when treating patients with chronic musculoskeletal pain from a biopsychosocial perspective. Four electronic databases (PubMed, Embase, CINAHL and ERIC) and the grey literature were searched. Studies were included if they investigated the experiences of physiotherapists in the treatment of chronic pain from a biopsychosocial perspective in primary care. Extracted data were discussed and sub grouped in themes following a qualitative content analysis approach. To align with current use of theories on behavior change, the resulting themes were compared to the Theoretical Domains Framework. After screening, twenty-four studies were included. Eight groups of barriers and facilitators were identified, thematically clustered in six themes: knowledge, skills, and attitudes; environmental context and resources; role clarity; confidence; therapeutic alliance; and patient expectations. The results of this review can be used to inform the development of implementation programs.

The responsiveness and interpretability of psychosocial patient-reported outcome measures in chronic musculoskeletal pain rehabilitation.

BACKGROUND: For several widely used patient-reported outcome measures (PROMs) in chronic musculoskeletal pain (CMSP) rehabilitation, it is still not known whether they are responsive to change, and what the smallest detectable change (SDC) and minimal clinically important change (MCIC) are. Knowledge of these values can be used to accurately interpret change scores in research and clinical practice. METHODS: In this retrospective cohort study, the responsiveness, the SDC and the MCIC of the mental components of the Research and Development 36-Item Health Survey (RAND-36), the Pain Catastrophizing Scale (PCS) and the Tampa Scale of Kinesiophobia (TSK) were investigated in CMSP patients. Responsiveness, the SDC and MCIC were determined by using both anchor and distribution-based methods. RESULTS: For all outcome measures, there was a progression from smallest to largest mean change scores between participants who did not perceive change and those who reported change after treatment. However, correlations of the Global Perceived Effect (GPE) with the change scores on the outcome measures were low. For all outcome measures, the SDC was larger than the MCIC. CONCLUSIONS: For this population, the questionnaires were shown not to be responsive. Furthermore, the questionnaires appeared not to be able to distinguish clinically important change from measurement error in individual patients. The finding of large measurement errors of PROMs is in line with previous research in pain rehabilitation. Using generic PROMs only, to examine changes in psychosocial status due to a pain rehabilitation programme, is therefore questionable. SIGNIFICANCE: This study shows that widely used generic psychosocial PROMs might not be responsive and not able to distinguish clinically important change from measurement error in individual chronic musculoskeletal pain patients. It therefore seems reasonable to reconsider the (compulsory) use of these PROMs for assessing the quality of pain rehabilitation programmes, and necessary to consider other, more objective, outcome measures for this purpose in this population.

Improving patient-practitioner interaction in chronic pain rehabilitation.

Stimulating patients to approach their pain from a biopsychosocial perspective is central to chronic pain rehabilitation. However, conversations between patients and their healthcare professionals about the social and psychological factors that may contribute to the continuation of pain and disability can be challenging. The current scientific literature does not sufficiently pinpoint the difficulties in patient-practitioner interaction on chronic pain, and it falls short of answering the question of how a joint exploration of the social and psychological factors that might be involved in the patient's pain and evolving disability can be enhanced. In this theoretical article, we introduce discursive psychology as a potentially valuable research perspective to gain a better understanding of the difficulties in patient-practitioner interaction in the context of chronic pain rehabilitation. Discursive psychology focuses on features of people's talk (e.g. that of patients and practitioners) and is concerned with the social practices that people perform as part of a specific interactional context. In this paper, we provide an introduction to the main theoretical notions of discursive psychology. We illustrate how discursive psychological analyses can inform our understanding of the specific sensitivities in conversations between patients with chronic pain and their practitioners. Finally, we address how a better understanding of these sensitivities offers a gateway towards improving these conversations.

Implications of process evaluation for clinical effectiveness and clinical practice in a trial on chronic shoulder complaints.

OBJECTIVE: The intervention process was evaluated in a randomised clinical trial on the effectiveness of a behavioural Graded Exercise Therapy (GET) programme for patients with chronic shoulder complaints in primary care settings. This process evaluation was done for three reasons: first, to know whether the programme was performed as planned; second, to know whether or not this treatment is feasible in normal practice; third, to identify needs for improvement of the protocol to facilitate implication. METHODS: We evaluated the extent to which the programme is being applied according to protocol, patient adherence to the programme and the suitability of the programme according to patients and physiotherapists. Twenty participating physiotherapists and 87 patients allocated to GET were asked to evaluate the intervention process. Furthermore, a sample of 10 patients, taken from the total number of 87 patients allocated to GET, was invited to take part in a focus group interview at the end of the study. We evaluated the intervention process using a treatment registration form filled in by the physiotherapists during treatment, evaluation forms filled in independently by physiotherapists and patients 26 weeks after the start of the treatment period, and information gathered during the focus group interview at the end of the study. RESULTS: GET was applied according to protocol to an acceptable extent, and participating patients showed satisfactory adherence to the programme. CONCLUSIONS: Clinical effectiveness of GET in this trial is not influenced by flaws in the application of the programme or by lack of patient adherence. PRACTICE IMPLICATIONS: The programme could be improved in terms of the process of goal-setting, and the implementation of GET could be facilitated if the programme is embedded in a multidisciplinary approach in primary care.

Active involvement and long-term goals influence long-term adherence to behavioural graded activity in patients with osteoarthritis: a qualitative study.

QUESTION: Why do some patients who have received a behavioural graded activity program successfully integrate the activities into their daily lives and others do not? DESIGN: Qualitative study. PARTICIPANTS: 12 patients were selected according to the model of deliberate sampling for heterogeneity, based on their success with the intervention as assessed on the Patient Global Assessment. INTERVENTION: Behavioural graded activity. OUTCOME MEASURES: Data from 12 interviews were coded and analysed using the methods developed in grounded theory. The interviews covered three main themes: aspects related to the content of behavioural graded activity, aspects related to experience with the physiotherapist, and aspects related to characteristics of the participant. RESULTS: Interview responses suggest that two factors influence long-term adherence to exercise and activity.First, initial long-term goals rather than short-term goals seem to relate to greater adherence to performing activities in the long term. Second, active involvement by participants in the intervention process seems to relate to greater adherence to performing activities in the long term. CONCLUSION: Although involvement of patients in the intervention process is already part of behavioural graded activity, it would be beneficial to emphasise the importance of active involvement by patients right from the start of the intervention. Furthermore, to increase the success of behavioural graded activity, physiotherapists should gain a clear understanding of the patient's initial motives in undergoing intervention.

Cut-Off Points for Mild, Moderate, and Severe Pain on the Numeric Rating Scale for Pain in Patients with Chronic Musculoskeletal Pain: Variability and Influence of Sex and Catastrophizing.

Objectives: The 0-10 Numeric Rating Scale (NRS) is often used in pain management. The aims of our study were to determine the cut-off points for mild, moderate, and severe pain in terms of pain-related interference with functioning in patients with chronic musculoskeletal pain, to measure the variability of the optimal cut-off points, and to determine the influence of patients' catastrophizing and their sex on these cut-off points. Methods: 2854 patients were included. Pain was assessed by the NRS, functioning by the Pain Disability Index (PDI) and catastrophizing by the Pain Catastrophizing Scale (PCS). Cut-off point schemes were tested using ANOVAs with and without using the PSC scores or sex as co-variates and with the interaction between CP scheme and PCS score and sex, respectively. The variability of the optimal cut-off point schemes was quantified using bootstrapping procedure. Results and conclusion: The study showed that NRS scores ≤ 5 correspond to mild, scores of 6-7 to moderate and scores ≥8 to severe pain in terms of pain-related interference with functioning. Bootstrapping analysis identified this optimal NRS cut-off point scheme in 90% of the bootstrapping samples. The interpretation of the NRS is independent of sex, but seems to depend on catastrophizing. In patients with high catastrophizing tendency, the optimal cut-off point scheme equals that for the total study sample, but in patients with a low catastrophizing tendency, NRS scores ≤ 3 correspond to mild, scores of 4-6 to moderate and scores ≥7 to severe pain in terms of interference with functioning. In these optimal cut-off schemes, NRS scores of 4 and 5 correspond to moderate interference with functioning for patients with low catastrophizing tendency and to mild interference for patients with high catastrophizing tendency. Theoretically one would therefore expect that among the patients with NRS scores 4 and 5 there would be a higher average PDI score for those with low catastrophizing than for those with high catastrophizing. However, we found the opposite. The fact that we did not find the same optimal CP scheme in the subgroups with lower and higher catastrophizing tendency may be due to chance variability.

Graded activity for low back pain in occupational health care: a randomized, controlled trial.

BACKGROUND: Low back pain is a common medical and social problem frequently associated with disability and absence from work. However, data on effective return to work after interventions for low back pain are scarce. OBJECTIVE: To determine the effectiveness of a behavior-oriented graded activity program compared with usual care. DESIGN: Randomized, controlled trial. SETTING: Occupational health services department of an airline company in the Netherlands. PATIENTS: 134 workers who were absent from work because of low back pain were randomly assigned to either graded activity (n = 67) or usual care (n = 67). INTERVENTION: Graded activity, a physical exercise program based on operant-conditioning behavioral principles, to stimulate a rapid return to work. MEASUREMENTS: Outcomes were the number of days of absence from work because of low back pain, functional status (Roland Disability Questionnaire), and severity of pain (11-point numerical scale). RESULTS: The median number of days of absence from work over 6 months of follow-up was 58 days in the graded activity group and 87 days in the usual care group. From randomization onward, graded activity was effective after 50 days of absence from work (hazard ratio, 1.9 [95% CI, 1.2 to 3.2]; P = 0.009). The graded activity group was more effective in improving functional status and pain than the usual care group. The effects, however, were small and not statistically significant. CONCLUSIONS: Graded activity was more effective than usual care in reducing the number of days of absence from work because of low back pain.

Reference Values of the Pain Disability Index in Patients With Painful Musculoskeletal and Spinal Disorders: A Cross-national Study.

STUDY DESIGN: Cross-sectional study. OBJECTIVE: To examine reference data for the Pain Disability Index (PDI) in Dutch and Canadian patient samples with a variety of musculoskeletal pain disorders and to test which potential factors are independently associated with the PDI score. SUMMARY OF BACKGROUND DATA: The PDI is a widely used generic instrument for measuring disability related to pain. It is unknown whether patients with spinal and other musculoskeletal diagnoses have different levels of disability when scored on the PDI. METHODS: Patients were referred to secondary and tertiary care centers in the Netherlands and Alberta, Canada, between 2009 and 2013. All patients filled out a baseline questionnaire including demographics and the PDI. After first consultation with a medical doctor, diagnoses were set by the medical specialist. Univariate general linear models were used to examine correlations between PDI scores and age, sex, country of residence, diagnosis, and work status. RESULTS: In total 6997 patients were included in this study: 1302 Canadian and 5695 Dutch patients. Mean PDI score of the total group was 37.8 ± 14.2. Reference values are presented and clustered into the following diagnostic groups: spinal nerve and intervertebral disc disorders; nonspecific back pain; rheumatic soft-tissue pain (widespread pain or fibromyalgia); spinal stenosis; and whiplash-associated disorder. The PDI score was significantly and relevantly associated with pain intensity (η explained variance from 20% to 25%), but not relevantly associated with age, sex, country of residence, and diagnostic group (η<3%). In the working subgroup, adding "current sick leave" as covariate increased the explained variance to 34%. CONCLUSION: Reference values of the PDI are presented. Patient ratings of disability on the PDI are relevantly associated with pain intensity and work status, but not with nationality or diagnostic group. Only minimal differences were identified between the various musculoskeletal diagnoses included. LEVEL OF EVIDENCE: N/A.

Pain reducing effect of three types of transcutaneous electrical nerve stimulation in patients with chronic pain: a randomized crossover trial.

Transcutaneous electrical nerve stimulation (TENS) is a frequently applied therapy in chronic pain although evidence for effectiveness is inconclusive. Several types of TENS, based on different combinations of frequency, pulse duration and intensity, exist. The precise mechanism of action and the relevance of combinations of stimulus parameters are still unclear. To compare the effectiveness of three types of TENS we conducted a randomized, single blinded crossover trial. Patients received two times a 2-week period of daily TENS treatment, separated by a washout period of 2 weeks. In total, 180 chronic pain patients were randomized into three groups. In group 1, high frequency, low intensity TENS (HFT) was compared with high frequency, high intensity TENS (HIT). In groups 2 and 3, HFT and HIT were compared with a control TENS (COT). The order of applying the different modalities of TENS in each group was also randomized. Primary outcome was the patient's overall assessment of effectiveness and pain reduction (VAS). No differences were found in patient's assessment or pain reducing effect between the three groups, indicating no superiority of one type of TENS. In total, 56% continued TENS after the 2-week treatment period. At 6 months, 42% of all patients still used TENS. We concluded that there were no differences in effectiveness for the three types of TENS used in this study. Because no placebo group was included, no definite conclusions on effectiveness of TENS in general in the treatment of chronic pain could be made.

Treatment of complex regional pain syndrome type I.

Reflex sympathetic dystrophy (RSD), also known as complex regional pain syndrome type I (CRPS I), is a disabling neuropathic pain syndrome. Controversy exists about the effectiveness of therapeutic interventions for the management of RSD/CRPS I. In order to ascertain appropriate therapies we conducted a review of existing randomized controlled trials of therapies for this disabling disease. Eligible trials were identified from the Cochrane, Pubmed, Embase and MEDLINE databases from 1966 through June 2000, from references in retrieved reports and from references in review articles. Twenty-six studies concerning treatment modalities were identified. Eighteen studies were randomized placebo-controlled trials and eight studies were randomized active-controlled trials. Three independent investigators reviewed articles for inclusion criteria using a 15-item checklist. Seventeen of the trials were of high quality according to the 15-item criteria. There was limited evidence for the effectiveness of these interventions because of the heterogeneity of treatment modalities. The search for trials concerning prevention of RSD/CRPS I resulted in two eligible studies. Both were of high quality and dealt with different interventions. There is limited evidence for their preventive effect.

Return-to-work interventions for low back pain: a descriptive review of contents and concepts of working mechanisms.

Low back pain is a major medical and social problem associated with disability, work absenteeism and high costs. Given the impact of the problem, there is a need for effective treatment interventions in occupational healthcare that aim at the prevention of chronic disability and the realisation of return to work. These so-called return-to-work (RTW) interventions are becoming increasingly popular. As well as questions concerning the effectiveness of RTW interventions, there are also important questions on the actual content and underlying concepts of these multifactorial intervention strategies. The purpose of this review is to examine the literature on the content and underlying concepts of RTW interventions for low back pain. A systematic literature search identified 14 randomised controlled trials (RCTs) evaluating the effects of 19 RTW interventions. The content and concepts of these RTW interventions are described, compared and discussed in this review. Further, the contents of the RTW interventions are classified by the use of predefined components (physical exercises, education, behavioural treatments and ergonomic measures). The identified RTW interventions varied with respect to the disciplines involved, the target population and the number and duration of sessions. The classification showed that physical exercises were a component of most of the selected interventions, followed by education, behavioural treatments and ergonomic measures. The most prevalent combination of components was the combination of physical exercises, behavioural treatment and education. However, the types of physical exercises, behavioural treatment and education varied widely among the RTW interventions. The described concepts for the physical exercises were an increase of muscle strength, coordination, range of motion of the spine and cardiovascular fitness, and a decrease of muscle tension. Education as a part of RTW interventions is believed to increase the understanding of patients regarding their disorder and treatment. Behavioural treatments were mainly based on the gate control theory of pain (psychophysiological processes are involved in pain perception) and/or the operant conditioning hypothesis (pain behaviour is determined by its consequences). No concepts were described for ergonomic measures. Finally, the plausibility of the described concepts is discussed. Future RCTs on this topic should evaluate the underlying concepts of the RTW intervention in addition to its effectiveness.

Comparison of multiple against single pain intensity measurements in complex regional pain syndrome type I: analysis of 54 patients.

OBJECTIVE: To describe the comparison of multiple and single pain ratings in patients with complex regional pain syndrome type I (CRPS I). DESIGN: Correlation, agreement, and reliability analyses were performed between the average pain intensity measured 3 times a day over a course of 4 days and one single pain rating (designated the "recalled average" pain, as assessed by the patient) before treatment and at 1-, 3-, and 6-month periods after treatment. PATIENTS: The patient population consisted of 54 patients with CRPS I in a randomized trial. RESULTS: The results show that both measurements correlate and have excellent agreement. Furthermore, both ratings measure significant pain reduction after treatment; "recalled average" pain, however, reflects greater change in pain intensity. CONCLUSIONS: In patients with CRPS I a single pain rating is an accurate predictor of the average pain measured by a multiple pain-rating test. Moreover, both assessments are accurate enough to determine changes in pain over time with an effective treatment.

A behavioural treatment for chronic shoulder complaints: concepts, development, and study design.

This paper discusses the rationale for and content of a newly developed treatment for shoulder complaints, and describes a randomised study which is currently being conducted to test effectiveness of the treatment. In current practice, approximately 50% of all patients with shoulder complaints mention limitations in the performance of daily activities and persisting pain after six months. To improve the functional ability of patients with chronic shoulder complaints, despite their pain, we have developed an operant behavioural and time-contingent graded exercise therapy programme for use in a primary care setting. We present the theory and conceptual model underlying this programme, report on its development and content, and describe the design of a randomised clinical trial to evaluate the programme's effectiveness and cost-effectiveness. One hundred and thirty-two patients who suffer from shoulder complaints for at least 3 months are being recruited in general practice. After inclusion in the study, patients are allocated randomly to the graded exercise therapy programme or to usual care. Questionnaires will be used to measure factors like severity of the main complaint, functional limitations of daily activities, perceived recovery, global health status, shoulder pain, generic health-related quality of life, and costs. These factors will be assessed at baseline, during treatment (6 weeks), and after treatment (12, 26, and 52 weeks).

Extensive validation of the pain disability index in 3 groups of patients with musculoskeletal pain.

STUDY DESIGN: A cross-sectional study design was performed. OBJECTIVE: To validate the pain disability index (PDI) extensively in 3 groups of patients with musculoskeletal pain. SUMMARY OF BACKGROUND DATA: The PDI is a widely used and studied instrument for disability related to various pain syndromes, although there is conflicting evidence concerning factor structure, test-retest reliability, and missing items. Additionally, an official translation of the Dutch language version has never been performed. METHODS: For reliability, internal consistency, factor structure, test-retest reliability and measurement error were calculated. Validity was tested with hypothesized correlations with pain intensity, kinesiophobia, Rand-36 subscales, Depression, Roland-Morris Disability Questionnaire, Quality of Life, and Work Status. Structural validity was tested with independent backward translation and approval from the original authors. RESULTS: One hundred seventy-eight patients with acute back pain, 425 patients with chronic low back pain and 365 with widespread pain were included. Internal consistency of the PDI was good. One factor was identified with factor analyses. Test-retest reliability was good for the PDI (intraclass correlation coefficient, 0.76). Standard error of measurement was 6.5 points and smallest detectable change was 17.9 points. Little correlations between the PDI were observed with kinesiophobia and depression, fair correlations with pain intensity, work status, and vitality and moderate correlations with the Rand-36 subscales and the Roland-Morris Disability Questionnaire. CONCLUSION: The PDI-Dutch language version is internally consistent as a 1-factor structure, and test-retest reliable. Missing items seem high in sexual and professional items. Using the PDI as a 2-factor questionnaire has no additional value and is unreliable.

Differences in physical functioning between relatively active and passive patients with Chronic Fatigue Syndrome.

OBJECTIVE: According to the Cognitive behavioral therapy (CBT) protocol for patients with Chronic Fatigue Syndrome (CFS), therapists are advised to categorize patients in relatively active and passive patients. However, evidence to support the differences in physical functioning between these subgroups is limited. Using the baseline data from a multicentre randomized controlled trial (FatiGo), the differences in actual and perceived physical functioning between active and passive patients with CFS were evaluated. METHODS: Sixty patients, who received CBT during the FatiGo trial were included. Based on the expert opinion and using the definitions of subgroups defined in the CBT protocols, the therapist categorized the patient. Data from an activity monitor was used to calculate actual physical functioning, physical activity, daily uptime, activity fluctuations and duration of rest during daily life. Perceived physical functioning was assessed by measuring physical activity, physical functioning and functional impairment with the Checklist Individual Strength, Short Form-36 and Sickness-Impact Profile 8. RESULTS: Relatively active patients have a significantly higher daily uptime and show significantly less fluctuations in activities between days. Passive patients experience a significantly lower level of physical functioning and feel more functionally impaired in their mobility. However, no significant differences were found in the other actual or perceived physical functioning indices. CONCLUSIONS: A clear difference in actual and perceived physical functioning between relatively active and passive patients with CFS as judged by their therapists could not be found. Future research is needed to form a consensus on how to categorize subgroups of patients with CFS.

Cognitive behavioural therapy versus multidisciplinary rehabilitation treatment for patients with chronic fatigue syndrome: study protocol for a randomised controlled trial (FatiGo).

BACKGROUND: Patients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to overcome their fatigue. Although there is no consensus, cognitive behavioural therapy is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment, a combination of cognitive behavioural therapy with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between multidisciplinary rehabilitation treatment and cognitive behavioural therapy is as yet unknown. The FatiGo (Fatigue-Go) trial aims to compare the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life in patients with chronic fatigue syndrome. METHODS: One hundred twenty patients who meet the criteria of chronic fatigue syndrome, fulfil the inclusion criteria and sign the informed consent form will be recruited. Both treatments take 6 months to complete. The outcome will be assessed at 6 and 12 months after the start of treatment. Two weeks after the start of treatment, expectancy and credibility will be measured, and patients will be asked to write down their personal goals and score their current performance on these goals on a visual analogue scale. At 6 and 14 weeks after the start of treatment, the primary outcome and three potential mediators-self-efficacy, causal attributions and present-centred attention-awareness-will be measured. Primary outcomes are fatigue severity and quality of life. Secondary outcomes are physical activity, psychological symptoms, self-efficacy, causal attributions, impact of disease on emotional and physical functioning, present-centred attention-awareness, life satisfaction, patient personal goals, self-rated improvement and economic costs. The primary analysis will be based on intention to treat, and longitudinal analysis of covariance will be used to compare treatments. DISCUSSION: The results of the trial will provide information on the effects of cognitive behavioural therapy and multidisciplinary rehabilitation treatment at 6 and 12 months follow-up, mediators of the outcome, cost-effectiveness, cost-utility, and the influence of treatment expectancy and credibility on the effectiveness of both treatments in patients with chronic fatigue syndrome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77567702.

Effectiveness of a behaviour graded activity program versus conventional exercise for chronic neck pain patients.

Chronic neck pain is a common complaint in the Netherlands with a point prevalence of 14.3%. Patients with chronic neck pain are often referred to physiotherapy and, nowadays, are mostly treated with exercise therapy. It is, however, unclear which type of exercise therapy is to be preferred. Therefore, this study evaluates the effectiveness of behaviour graded activity (BGA) compared with conventional exercise (CE) for patients with chronic neck pain. Eligible patients with non-specific chronic neck were randomly allocated to either BGA or CE. Primary treatment outcome is the patient's global perceived effect concerning recovery from complaint and daily functioning. Outcome assessment was performed at baseline, and at 4, 9, 26, and 52 weeks after randomization. Effectiveness was examined with general estimating equations analyses. Baseline demographics and patient characteristics were well balanced between the two groups. Mean age was 45.7 (SD 12.4) years and the median duration of complaints was 60 months. The mean number of treatments was 6.6 (SD 3.0) in BGA and 11.2 (SD 4.1) in CE. No significant differences between treatments were found in their effectiveness of managing patients with chronic neck pain. In both BGA and CE some patients reported recovery from complaints and daily function but the proportion of recovered patients did not exceed 50% during the 12-month follow-up period. Both groups showed clinically relevant improvements in physical secondary outcomes. International Standard Randomised Controlled Trial Number: ISRCTN88733332.